12 results
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7ms
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Sources: EU EUDAMED, US FDA
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES SARS-CoV-2 Assay
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 24, 2022
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES SARS-CoV-2 Assay, REF: 50-10047
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·November 2, 2022
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
FDA Enforcement
Class II
·Ongoing·Remel, Inc·March 26, 2025
Intelerad InteleShare software, with ProViewer component
FDA Enforcement
Class II
·Ongoing·DICOM Grid, Inc.·December 24, 2025
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Enforcement
Class II
·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·October 5, 2022